JP2017506139A - Intraocular fluid discharge device and manufacturing method thereof - Google Patents

Abstract

An aspect of the present disclosure is for an intraocular fluid drainage device comprising a stabilization system. The stabilization system can further include a collagen-containing material that includes a plate and covers at least a portion of the top surface of the plate, and / or a viscoelastic material that covers at least a portion of the top surface of the plate. The plate is formed of a flexible material and includes a tube holding structure that is integrally formed with the plate, the tube holding structure being at least partially surrounded by the tube holding structure when moving the tube. The tube is configured to be held on the plate. The tube retaining structure may comprise a low profile contoured ridge and / or a channel formed by cutting away or having a U shape. The plate has at least one plate channel, including a plate channel configured to support a tube. The plate can further comprise a reservoir. [Selection] Figure 1A

Description

  The present disclosure relates generally to the field of ophthalmology. In particular, the present disclosure relates to implantable intraocular devices including intraocular fluid drainage devices. More specifically, the present disclosure relates to a glaucoma drainage device (hereinafter referred to as “GDD”), a method of manufacturing GDD, and a method of implanting GDD.

  Glaucoma, if left unattended, causes irreversible blindness. In 2010, 60 million people were diagnosed with glaucoma, of which 8 million progressed to blindness. Glaucoma develops when intraocular pressure (IOP) in the eye rises above normal levels due to the influx of aqueous fluid exceeding the outflow. Although drug therapy is effective, compliance is a problem because drug therapy usually requires a multi-drug regimen. For example, in patients undergoing drug therapy, studies have shown a 50% compliance rate for 6 months of drug therapy. When drug therapy is ineffective, invasive trabeculectomy is typically used. Although trabeculectomy may be effective, it has been shown that the failure rate 5 years after surgery is 46.9% mainly due to the formation of scar tissue.

  A glaucoma drainage device (hereinafter referred to as “GDD”) can be used for patients who are refractory to drug treatment and patients whose trabeculectomy has failed. There is currently a lot of evidence that GDD, which is typically used only in cases with very high refractory refractories, is as safe and effective as I trabeculectomy in controlling IOP. In some cases, GDD has been found to be more effective than trabeculectomy for controlling IOP.

  GDD, known as a glaucoma filtration device or aqueous humor shunt, is a surgical implant that allows intraocular fluids to drain out of the eye, thereby reducing intraocular pressure. GDD has been used since the early 1970s, and two standard designs have survived. So far, the design of GDD has not made much progress.

  The challenge is to improve the GDD design to eliminate the problems associated with currently available GDDs. For example, currently available GDDs show that the failure rate of a traditional instrument called Baerveldt is 36% five years after surgical implantation, while the conventional instrument called Ahmed has a failure rate of 44%. It is shown that. Such failure rates are due to flow obstruction, inflammation, and fibrous encapsulation associated with currently available GDDs.

  Accordingly, there is a need to provide a glaucoma drainage device (GDD) that eliminates or at least ameliorates one or more of the above disadvantages. Non-limiting exemplary embodiments of the GDD of the present disclosure meet such needs.

  The present disclosure relates to a glaucoma drainage device (GDD) having an improved design over currently available glaucoma drainage devices (GDD). The improved GDD design of the present disclosure can allow for improved surgical implantation methods for implanting GDDs. In addition, the improved design of the GDD of the present disclosure can prevent complications associated with currently available GDDs. Moreover, the improved design of the GDD of the present disclosure can improve the ability to reduce intraocular pressure (IOP) to an acceptable level over currently available GDDs.

  In general, the improvements and success rates associated with the GDDs of the present disclosure are likely to depend largely on the GDD design, the materials used to manufacture the GDD, and / or the GDD manufacturing method.

  The present disclosure also relates to GDD plates, the design of which can be optimized for filtration follicle formation and / or fluid control.

  The present disclosure also relates to a GDD tube, which can control fluid, facilitate insertion of the distal end of the tube, and / or facilitate length correction and / or correction at the proximal end of the tube. It can be designed to make it possible.

  The present disclosure also relates to a mechanism designed to control the tube diameter of the GDD, which can reduce the tube diameter from the first 4 to 8 weeks after surgical implantation. At 8 weeks after surgical implantation and / or after 8 weeks from surgical implantation, the diameter of the tube is increased to the original diameter and / or final diameter, thereby draining from the eye It can affect the speed of the fluid.

  In addition, the present disclosure relates to a stable system, ie a fluid flow control system, which can prevent complications associated with currently available GDDs. This stabilization system can add additional resistance to the fluid flow, thereby functioning as a flow restrictor to prevent hypotony immediately after surgery / surgical implantation. In addition, this stabilization system can serve as a spacer that prevents the conjunctiva from adhering to the scleral valve, thereby enhancing the formation of the filter bleb. Increased formation of follicles allows for better control of fluid flow over an extended period of time, thereby improving the ocular hypertension phase typically seen one month after post-surgical / surgical implantation.

  The new and unique design of the GDD of the present disclosure can use materials that have a proven track record and are approved by regulations. The GDDs of the present disclosure are improved surgical implants, good postoperative outcomes, patient comfort, and / or instrument life over 5 years from surgical implantation (5 years is typical of currently available GDDs) A long life after surgical implantation).

  A first aspect of the present disclosure is a plate for an implantable intraocular device that can comprise a flexible material and a tube retention structure integrally formed with the plate to move the tube. Sometimes the tube retention structure provides a plate that is configured to secure the tube to the plate. In some embodiments, the implantable intraocular device can include an intraocular fluid drainage device. In some embodiments, the implantable intraocular device can include a glaucoma drainage device.

  In some embodiments, the tube retaining structure can comprise a low profile contoured ridge. In some embodiments, the tube retention structure can comprise a tube receiving channel having a U shape.

  In some embodiments, the plate can further comprise at least one plate channel. In some embodiments, the at least one plate channel can be formed by cutting away the plate. In some embodiments, the at least one plate channel can comprise a diameter that matches the outer diameter of the tube.

  In some embodiments, the plate can further comprise a reservoir. In some embodiments, the reservoir can be formed by creating a recess.

  In some embodiments, the plate can further include a collagen-containing material that covers at least a portion of the top surface of the plate and / or at least a portion of the reservoir. In some embodiments, the collagen-containing material can include materials including pericardium, pericardial tissue, pericardial patch, donor sclera, or a combination of one or more thereof.

  In some embodiments, the plate can further include a viscoelastic material that covers at least a portion of the top surface of the plate and / or at least a portion of the reservoir. In some embodiments, the viscoelastic material can cover at least a portion of the collagen-containing material.

In some embodiments, the width of the plate (left-right direction) can be about 24 mm or less. In some embodiments, the plate length (front-rear direction) can be about 16 mm or less. In some embodiments, the surface area of the plate can be from about 250 mm ² to about 360 mm ² .

  In some embodiments, the plate can further comprise a tube receiving hole, and the diameter of the tube receiving hole can correspond to the outer diameter of the tube.

  A second aspect of the present disclosure provides a tube for an implantable intraocular device that can comprise a length having a proximal end and a distal end and a biodegradable cuff.

  A third aspect of the present disclosure provides a tube for an implantable intraocular device that can comprise a length having a proximal end and a distal end and an outer diameter of 0.7 mm or less. .

  A fourth aspect of the present disclosure is a tube for an implantable intraocular device, the tube having a length having a proximal end and a distal end, the distal end being chamfered. Provide a tube that has

  A fifth aspect of the present disclosure provides a tube for an implantable intraocular device that can comprise a length having a proximal end and a distal end and one or more micropores.

  In some embodiments, the tube can include a drain tube. In some embodiments, the implantable intraocular device can include an intraocular fluid drainage device. In some embodiments, the implantable intraocular device can include a glaucoma drainage device.

  In some embodiments, the length of the tube can be from about 10 mm to about 20 mm. In some embodiments, the inner diameter of the tube can be about 0.3 mm or less. In some embodiments, the inner diameter of the tube can be from about 0.1 mm to about 0.3 mm. In some embodiments, the inner diameter of the tube can be about 0.1 mm or less.

  In some embodiments, the inner diameter of the one or more micropores can be approximately equal to the dimension of the inner diameter of the tube. In some embodiments, the tube can further comprise two or more micropores, the two or more micropores being disposed along the same longitudinal axis of the tube. In some embodiments, the tube can further comprise two or more micropores, the two or more micropores being staggered along the length of the tube.

  In some embodiments, the proximal end of the tube can be removably attached to a plate of an implantable intraocular device, and its distal end is configured for insertion into the eye. In some embodiments, the chamfered distal end of the tube can be chamfered at about 30 °.

  In some embodiments, the biodegradable cuff is PLGA (poly (lactic-co-glycolic acid)), PDLGA (poly (DL-lactide-co-glycolide)), biodegradable polymer, biocompatible polymer, Or the substance containing what combined these 1 or more types can be included.

  In some embodiments, the length of the biodegradable cuff can correspond to the curvature of the eye. In some embodiments, the biodegradable cuff length can be about 2 mm or less. In some embodiments, the diameter of the biodegradable cuff can be one that reduces the inner diameter of the tube, which reduces the fluid flow rate through the tube to about 2 μL / min or less. it can. In some embodiments, the biodegradable cuff can have a wall thickness of about 0.5 mm or less.

  In some embodiments, the biodegradable cuff can begin to degrade mechanically, structurally, or compositionally from about 4 weeks after implantation to about 8 weeks after implantation, but less than 4 weeks after implantation, And will not begin to degrade in more than 8 weeks after implantation.

  In some embodiments, the biodegradable cuff can be placed from about 6 mm to about 10 mm from the distal end of the tube.

  A sixth aspect of the present disclosure provides an implantable intraocular device that can comprise the plate and the tube. In some embodiments, the implantable intraocular device can include an intraocular fluid drainage device. In some embodiments, the implantable intraocular device can include a glaucoma drainage device.

  A seventh aspect of the present disclosure is a method of manufacturing the above plate, which can include providing a medical grade elastomeric material and molding the medical grade elastomeric material. I will provide a. In some embodiments, the method of manufacturing the plate can further include polishing the molded medical grade elastomeric material.

  An eighth aspect of the present disclosure is a method of manufacturing the above-described tube, comprising: preparing a medical grade elastomer material; and extruding the medical grade elastomer material to form a tube. Methods that can be included are provided.

  A ninth aspect of the present disclosure provides a method of manufacturing the above implantable intraocular device, which can include providing the plate and preparing the tube. .

  In some embodiments, the method of manufacturing an implantable intraocular device described above can further include passing a tube through the tube receiving hole. In some embodiments, the method of manufacturing an implantable intraocular device described above can further include manually passing the tube through the tube receiving hole.

  In some embodiments, the method of manufacturing an implantable intraocular device described above can further include overmolding the plate into a tube.

  A tenth aspect of the present disclosure is a method of implanting the above implantable intraocular device, wherein a subtenon / subconjunctival space having a dimension corresponding to a dimension of the plate is formed in the eye, and Place the plate within the subconjunctival space to cover the membrane, secure the plate with sutures, insert the distal end of the tube into the anterior chamber of the eye, and connect the proximal end of the tube Providing a method that can include customizing the length of the tube by cutting.

  An eleventh aspect of the present disclosure is a method for controlling intraocular pressure, the preparation of the implantable intraocular device as described above, and the method of implanting the implantable intraocular device as described above. Implanting an intraocular device into the eye.

  A twelfth aspect of the present disclosure is a method for preventing complications associated with currently available glaucoma drainage devices, comprising providing the implantable intraocular device described above; and Using a method of implantation, a method is provided that can include implanting the above implantable intraocular device into the eye.

  A thirteenth aspect of the present disclosure is a stabilization system for an implantable intraocular device, comprising a plate, a collagen-containing material that covers at least a portion of the top surface of the plate, and / or at least a portion of the top surface of the plate. A stabilizing system is provided that can comprise a viscoelastic material covering. In some embodiments, the plate can comprise a reservoir.

  Embodiments of the present disclosure will be described with reference to the following drawings.

FIG. 3 shows various types of glaucoma drainage devices (GDDs) according to an embodiment of the present disclosure. FIG. 3 shows various types of glaucoma drainage devices (GDDs) according to an embodiment of the present disclosure. Fig. 2 shows a plate according to an embodiment of the present disclosure. Specifically, various types of views of a plate according to an embodiment of the present disclosure are shown, the plate comprising a tube holding structure with a ridge. Fig. 2 shows a plate according to an embodiment of the present disclosure. Specifically, various types of views of a plate according to an embodiment of the present disclosure are shown, the plate comprising a tube holding structure with a ridge. Fig. 2 shows a plate according to an embodiment of the present disclosure. Specifically, various types of views of a plate according to an embodiment of the present disclosure are shown, the plate comprising a tube holding structure with a ridge. Fig. 2 shows a plate according to an embodiment of the present disclosure. Specifically, a plate according to one embodiment of the present disclosure is shown, the plate comprising a tube holding structure including a U-shaped structure. Fig. 2 shows a plate according to an embodiment of the present disclosure. Specifically, a plate according to one embodiment of the present disclosure is shown, the plate comprising a tube holding structure including a U-shaped structure. Fig. 2 shows a plate according to an embodiment of the present disclosure. Specifically, a plate according to one embodiment of the present disclosure is shown, the plate comprising two or more plate channels. FIG. 4 shows a view of a plate according to one embodiment of the present disclosure. FIG. 4 shows a view of a plate according to one embodiment of the present disclosure. FIG. 6 shows a cross-sectional view of a plate tube retention structure according to an embodiment of the present disclosure, the tube retention structure comprising a ridge. Fig. 2 shows a plate according to various embodiments of the present disclosure. Fig. 2 shows a plate according to various embodiments of the present disclosure. Fig. 2 shows a plate according to various embodiments of the present disclosure. FIG. 4 shows various types of views of a tube according to an embodiment of the present disclosure. FIG. 4 shows various types of views of a tube according to an embodiment of the present disclosure. FIG. 3 shows various types of views of a tube according to an embodiment of the present disclosure, the tube comprising micropores. Use of currently available variants of glaucoma drainage device implants (modified to include bovine pericardial tissue (eg Tutopatch®) and cross-linked hyaluronic acid (eg Healaflow®)); Shows the results of a clinical study comparing the use of an unmodified version of the glaucoma drainage device implant currently available (used as a control). Specifically, the eyes of all patients / subjects in the experimental group (group treated with a currently available variant of glaucoma drainage device implant) and the control group (unmodified version of the glaucoma drainage device implant currently available) The change in IOP during the follow-up period of 6 months after surgery for all patients / subjects' eyes. Use of currently available glaucoma drainage device implant variants (modified to include bovine pericardial tissue (eg, Tutopatch)) and cross-linked hyaluronic acid (eg, Healaflow), and currently available glaucoma drainage devices Results of a clinical study comparing the use of an unmodified implant (used as a control). Specifically, in the follow-up period of 6 months before and after surgery, the number of administrations of anti-glaucoma drugs required in the experimental group treated with Tutopatch and Healaflow, and the control group without using Tutopatch and Healaflow Shows the number of anti-glaucoma medications needed in. Tabletop data results of natural flow simulation comparing the use of the glaucoma drainage device (GDD) 2 according to the present disclosure with the use of a variant of the device Baerveldt® with a 200 micrometer seam formed in the tube. Show. More specifically, the transition of the first set of intraocular pressure reduction simulation over time when the fluid is discharged from the deformed version of the instrument Baerveldt is shown. FIG. 6 shows desktop data results of a natural flow simulation comparing the use of a glaucoma drainage device (GDD) 2 according to the present disclosure with the use of a variant of the device Baerveldt with a 200 micrometer seam formed in the tube. More specifically, the transition of the first set of intraocular pressure simulation with respect to the flow rate is shown, and the relationship between the intraocular pressure and the flow rate of the fluid passing through the variant of the instrument Baerveldt is shown. FIG. 6 shows desktop data results of a natural flow simulation comparing the use of a glaucoma drainage device (GDD) 2 according to the present disclosure with the use of a variant of the device Baerveldt with a 200 micrometer seam formed in the tube. More specifically, it shows the transition of the second set of intraocular pressure reduction simulation over time when the fluid is discharged from the deformed version of the instrument Baerveldt. FIG. 6 shows desktop data results of a natural flow simulation comparing the use of a glaucoma drainage device (GDD) 2 according to the present disclosure with the use of a variant of the device Baerveldt with a 200 micrometer seam formed in the tube. More specifically, the transition of the second set of intraocular pressure simulation with respect to the flow rate is shown, and the relationship between the intraocular pressure and the flow rate of the fluid passing through the variant of the instrument Baerveldt is shown. FIG. 6 shows desktop data results of a natural flow simulation comparing the use of a glaucoma drainage device (GDD) 2 according to the present disclosure with the use of a variant of the device Baerveldt with a 200 micrometer seam formed in the tube. More specifically, the transition of the first set of intraocular pressure reduction simulation over time when the glaucoma discharge device (GDD) 2 according to the present disclosure is used is shown. FIG. 6 shows desktop data results of a natural flow simulation comparing the use of a glaucoma drainage device (GDD) 2 according to the present disclosure with the use of a variant of the device Baerveldt with a 200 micrometer seam formed in the tube. More specifically, it shows the transition of the first set of intraocular pressure simulations with respect to the flow rate, the intraocular pressure and the flow rate of fluid through such a glaucoma drainage device (GDD) 2 according to the present disclosure, The relationship with the flow rate of the fluid which changes with intraocular pressure is shown. FIG. 6 shows desktop data results of a natural flow simulation comparing the use of a glaucoma drainage device (GDD) 2 according to the present disclosure with the use of a variant of the device Baerveldt with a 200 micrometer seam formed in the tube. More specifically, the transition of the second set of intraocular pressure reduction simulation over time when the glaucoma discharge device (GDD) 2 according to the present disclosure is used is shown. FIG. 6 shows desktop data results of a natural flow simulation comparing the use of a glaucoma drainage device (GDD) 2 according to the present disclosure with the use of a variant of the device Baerveldt with a 200 micrometer seam formed in the tube. More specifically, it shows the transition of the second set of intraocular pressure simulations with respect to the flow rate, the intraocular pressure and the flow rate of fluid through such a glaucoma drainage device (GDD) 2 according to the present disclosure, The relationship with the flow rate of the fluid which changes with intraocular pressure is shown. FIG. 7 shows desktop data results for constant flow simulation comparing the use of the glaucoma drainage device (GDD) 2 according to the present disclosure with the use of a variant of the device Baerveldt with a 200 micrometer seam formed in the tube. . More specifically, the transition of three sets of intraocular pressure simulations with respect to the flow rate when using a modified version of the instrument Baerveldt is shown. FIG. 7 shows desktop data results for constant flow simulation comparing the use of the glaucoma drainage device (GDD) 2 according to the present disclosure with the use of a variant of the device Baerveldt with a 200 micrometer seam formed in the tube. . More specifically, FIG. 9A shows the average transition of three sets of intraocular pressure simulations with respect to the flow rate. FIG. 7 shows desktop data results for constant flow simulation comparing the use of the glaucoma drainage device (GDD) 2 according to the present disclosure with the use of a variant of the device Baerveldt with a 200 micrometer seam formed in the tube. . More specifically, the transition of two sets of intraocular pressure simulations with respect to the flow rate when the glaucoma discharge device (GDD) 2 according to the present disclosure is used is shown. FIG. 7 shows desktop data results for constant flow simulation comparing the use of the glaucoma drainage device (GDD) 2 according to the present disclosure with the use of a variant of the device Baerveldt with a 200 micrometer seam formed in the tube. . More specifically, FIG. 9C shows the average transition of two sets of intraocular pressure simulations with respect to the flow rate.

  In the following detailed description, reference is made to the accompanying drawings that form a part hereof. In the drawings, similar symbols typically identify similar components, unless context dictates otherwise. The illustrative embodiments described in the detailed description, drawings, and claims are not meant to be limiting. Other embodiments may be used and other changes may be made without departing from the spirit or scope of the subject matter presented herein. Unless otherwise specified, the terms “comprising”, “consisting”, “having”, and “including”, as used herein, and grammatical variations thereof only include the listed elements. And is intended to represent an “open” or “inclusive” phrase so that additional elements not listed may also be included. As used herein, the term “about” means in the context of a component concentration, condition, measurement, or calculated value ± 10% of the indicated value, eg, the indicated value. ± 5% of indicated value, ± 4% of indicated value, ± 3% of indicated value, ± 2% of indicated value, ± 1% of indicated value, indicated value Means ± 0.5% of ± or ± 0% of the indicated value.

  Throughout this disclosure, certain embodiments may be disclosed in a range format. It should be understood that the description in range form is merely for convenience and brevity and should not be construed as strictly limiting the breadth of the disclosed range. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges and individual numerical values within that range. For example, descriptions of ranges such as 1 to 6 include partial ranges such as 1 to 3, 1 to 4, 1 to 5, 2 to 4, 2 to 6, 3 to 6, and individual numbers within the range, For example, 1, 2, 3, 4, 5, and 6 should be considered as specifically disclosed. This applies regardless of the extent of the range.

Embodiments of the glaucoma drainage device according to the present disclosure (a) significantly facilitate implantation and manipulation during implantation, (b) significantly facilitate maintenance of anterior chamber stability after surgery, (c) Substantially or essentially eliminate post-operative complications such as hypotony, and (d) reduce or minimize the complications typically associated with implantation in the superficial anterior chamber, ie The glaucoma drainage device is structured in such a way that it is suitable for use in any case.

  1A-1B show various types of views of a glaucoma drainage device (GDD) 2 according to one embodiment of the present disclosure. The GDD 2 can comprise a plate 4 and a tube 6 (eg, the plate 4 is configured to support the elongate tube 6 along a plurality of longitudinal portions of the tube). The tube 6 can consist of a discharge tube 6. The tube 6 can consist of an anterior chamber tube 6. In some embodiments, the tube 6 can be adjustable and / or modifiable.

  In some embodiments, the plate 4 can comprise a reservoir 8. The reservoir 8 on and / or in the plate 4 can serve as a collection point for aqueous humor during the implantation of the GDD 2, thereby enhancing the formation of filter bleb. In some embodiments, the reservoir 8 can hold collagen-containing material on and / or around portions of the plate 4. In some embodiments, the collagen-containing material can further comprise elastin. In some embodiments, the collagen-containing material can include pericardium, pericardial tissue, and / or donor sclera. In some embodiments, the collagen-containing material can be flexible. In some embodiments, the collagen-containing material can be lyophilized. In some embodiments, the collagen-containing material can include a patch.

  In some embodiments, the reservoir 8 can hold a viscoelastic material on and / or around the plate 4. In some embodiments, the viscoelastic material can include sodium hyaluronate and / or cross-linked hyaluronic acid. In some embodiments, the viscoelastic material can include an inert viscoelastic material.

  In some embodiments, the reservoir 8 can hold a collagen-containing material on and / or around the plate 4 and / or can hold a viscoelastic material on and / or around the plate 4.

  In some embodiments, the plate 4 excludes or does not include a reservoir. In some embodiments, if the plate 4 does not comprise a reservoir, the collagen-containing material and / or viscoelastic material can be applied on and / or around portions of the plate 4.

  In some embodiments, the plate 4 can comprise one or more plate channels 10 on and / or in the plate 4. The tube 6 can be inserted into the plate channel 10. The plate channel 10 allows the tube 6 to be cut to a desired length so that it can be fitted into the plate channel 10. The plate channel 10 can be used to secure the tube 6 on and / or in the plate 4 during and after implantation. In some embodiments, the plate channel 10 may be formed by cutting away the top surface 12 of the plate 4 so that the recess has a length that extends along the length of the plate channel 10. A recess extending along the length of the plate channel 10 can hold and / or secure the tube 6 within the plate channel 10.

  The plate 4 can allow for improved implantation, improved adhesion, and / or improved fluid diffusion into the subconjunctival space. In some embodiments, the plate 4 can be made of a flexible material (eg, silicone). In some embodiments, the plate 4 can have a low profile profile. The low profile contour plate 4 can reduce the orbital volume occupied by the plate 4 and, as a result, facilitate the insertion and / or conjunctival suture of the plate 4 during implantation. The formation of filtration follicles can also be improved by the plate 4 having a low outline shape. With the plate 4 having a low outline shape, the protrusion from the conjunctiva can be reduced and / or the conjunctival elongation can be suppressed, thereby improving the formation of filtration follicles after implantation. In the long run, good filtering bleb can improve eye movement and fluid flow controllability in the patient.

  In some embodiments, the plate 4 can be treated (eg, by surface polishing) to give the plate 4 a smooth profile. This smooth profile can reduce fibrosis and / or scar tissue, thereby improving filter follicle formation. In some embodiments, the plate 4 can be made of a flexible material (eg, silicone), and the elastic modulus of the flexible material can be comparable to the sclera. The plate 4 and / or the adjustable tube 6 allow the GDD 2 to be more easily implanted in the patient and reduce patient discomfort after implantation.

  In some embodiments, the tube 6 can comprise a length having a proximal end 14 inserted into the plate channel 10 and a distal end 16 inserted into the eye. In some embodiments, the tube 6 may comprise or have a cuff 18 that is placed and / or positioned along a portion of the length of the tube 6, which cuff 18 is The outer peripheral surface defined by the said part of the tube 6 is covered. In some embodiments, the cuff 18 can comprise a biodegradable cuff 18 or a biocompatible erodible cuff 18 that is placed along a portion of the length of the tube 6 and The cuff 18 covers the outer peripheral surface defined by that part of the tube 6.

  The distal end 16 of the tube 6 can be inserted into the anterior chamber of the patient's eye. In some embodiments, the tube 6 can be adjustable and / or deformable. In some embodiments, the design of the tube 6 allows the surgeon or clinician to keep the proximal end 14 of the tube 6 connected / attached to the plate 4 and the distal end 16 of the tube 6 to the patient's eye. While remaining in the anterior chamber, the tube 6 can be customized to the required length for each patient. Once the desired length is confirmed, the proximal end 14 of the tube 6 can be cut while the distal end 16 of the tube 6 remains in the anterior chamber of the patient's eye. In contrast, what is currently done with currently available GDDs, based on rough estimates, is to cut the distal end of the tube to the desired length, or insert the distal end of the tube into the eye, Confirming the desired length, removing the distal end of the tube from the eye, cutting the distal end of the tube, and then reinserting the cut distal end of the tube into the eye.

  In some embodiments, the distal end 16 has an atraumatic rim to further reduce the likelihood of the patient being injured during insertion and placement of the tube 6 into the eye. The distal end 16 of the tube 6 can be smooth. In some embodiments, the distal end 16 of the tube 6 does not include a cutting edge that can harm the eye. In contrast, what is currently done with currently available GDDs is to cut the tube at the distal end in order to obtain a tube of the desired length. During insertion and / or placement, it may have one or more cutting edges that may damage the eyes.

  In some embodiments, the outer shape of the tube 6 can be reduced to prevent damage to intraocular tissue (eg, a smaller diameter and / or a smaller diameter can be used).

  In some embodiments, the proximal end 14 of the tube 6 is coupled to the plate 4 and the distal end 16 of the tube 6 is placed or inserted into the anterior chamber (AC) of the eye. The plate 4 can be embedded under the conjunctiva. Once attached to the eye, excess fluid can be drained from the AC via the tube 6 and diffused through the plate 4, thereby reducing excess intraocular pressure (IOP).

  In some embodiments, the cuff 18 can be placed and / or placed along a portion of the length of the tube 6. In some embodiments, a cuff 18 placed and / or positioned along a longitudinal portion of the tube 6 will allow fluid flow for the first 4-8 weeks after implanting the GDD2. To limit and / or control, the original diameter of the part of the tube 6 covered by the cuff 18 from the outer space can be reduced. As the cuff 18 disassembles, the cuff 18 gradually weakens the pressure on the portion of the tube 6 covered by the cuff 18, thereby gradually reducing the portion of the tube 6 covered by the cuff 18. Release and / or allow the portion of the tube 6 covered by the cuff 18 to gradually return to the original diameter of the portion of the tube 6.

  In some embodiments, the cuff 18 that is placed and / or placed in a longitudinal portion of the tube 6 generates resistance to abrupt fluid flow for a minimum of about 4 weeks after implantation. , Thereby preventing excessive fluid drainage (which can lead to hypotony in the early stages (eg, before fibrous tissue is formed on the plate 4 of GDD2)) and It can occur up to about 8 weeks after implantation, thereby increasing spill volume and minimizing excess fluid retention (which can cause post-operative IOP elevation). .

  In some embodiments, the cuff 18 can begin to degrade and / or dissipate (and thereby its mechanical strength and / or mechanical properties) from about 4 weeks after implantation to about 8 weeks after implantation. Will not begin to degrade and / or dissipate in less than 4 weeks after implantation and more than 8 weeks after implantation.

  In some embodiments, the cuff 18 does not begin to degrade (and thereby begins to lose its mechanical strength and / or mechanical properties) less than 4 weeks after implantation, thereby causing excess fluid. , Which may lead to hypotony in the early stages (eg, before fibrous tissue is formed on the plate 4 of GDD2) and does not begin to degrade more than 8 weeks after implantation, thereby The outflow can be increased to minimize excess fluid retention (which can cause post-operative IOP elevation).

  That is, the cuff 18 can restrict and / or control the fluid from flowing out of the eye at an early stage to prevent hypotension before the fibrous tissue is formed on the plate 4. In addition, the gradual loss of the mechanical strength and / or mechanical properties of the cuff 18 may prevent post-operative IOP elevation at a later stage (eg, after fibrous tissue has formed on the plate). it can.

  In some embodiments, the diameter of the portion of the tube 6 covered by the cuff 18 increases in size to its original diameter and / or final diameter in about 8 weeks after implantation, thereby allowing fluid By increasing the flow rate of the fluid, the flow rate of the fluid flowing out from the eye can be influenced. In some embodiments, the diameter of the portion of the tube 6 covered by the cuff 18 increases in size to its original diameter and / or final diameter in about 8 weeks after implantation, thereby allowing fluid By increasing the flow rate of the fluid, the flow rate of the fluid flowing out from the eye can be influenced.

  In some embodiments, the cuff 18 can remain physically present even after loss of its mechanical strength and / or mechanical properties. In some embodiments, the cuff 18 disintegrates and loses its mechanical strength and / or mechanical properties and / or dissipates to lose its mechanical strength and / or mechanical properties. Later, it can still have a physical presence.

  In some embodiments, the cuff 18 may completely degrade and lose its mechanical strength and / or mechanical properties at about 8 weeks after implantation or about 8 weeks after implantation. it can.

  In some embodiments, the cuff 18 completely degrades at about 8 weeks after implantation, or about 8 weeks after implantation, completely losing its mechanical strength and / or mechanical properties, The diameter of the portion of the tube 6 covered by the cuff 18 can be increased to the original diameter of the tube 6 prior to placing and / or placing the cuff 18 on the tube 6.

  About 4 weeks after implantation, some fibrous encapsulation occurs around the portion of the plate 4 of GDD2, creating some resistance to fluid flow and preventing hypotony.

  2A-2F illustrate a plate 4 according to an embodiment of the present disclosure.

  2A-2C show various types of views of the plate 4 according to one embodiment of the present disclosure, the plate 4 comprising a tube holding structure 20. In some embodiments, the tube retaining structure 20 can include a ridge 20. In some embodiments, the plate 4 can be integrally formed with the tube retaining structure 20. In some embodiments, the plate 4 is integrally formed with the ridge 20.

  In some embodiments, the ridge 20 can comprise a low profile profile. In some embodiments, the height of the ridge 20 can be about 0.3 mm or less, and the total height of the plate 4 (including both the plate height and the height of the ridge) is about 1. 3 mm or less. In some embodiments, the height of the ridges 20 can be about 0.3 mm or less and the total height of the plate 4 is about 1.25 mm or less. In some embodiments, the length of the ridge 20 can be at least 2 mm to about 4 mm. In some embodiments, the length of the ridge 20 can be about 4 mm. In some embodiments, the width of the ridge 20 can be at least about 1 mm. In some embodiments, the width of the ridge 20 can be about 1 mm.

  The profile of the plate 4 can be reduced in order to improve the formation of filtration follicles by means of the ridge 20 with a low profile. In other words, the overall thickness of the plate 4 with the ridges 20 can be reduced and / or the overall height can be reduced, thereby improving the formation of filter cells.

  In some embodiments, the low profile contour ridges 20 of the plate 4 can contribute to improving the formation of filtration follicles after implantation. In some embodiments, the reservoir 8 of the plate 4 can contribute to improving the formation of filtration follicles after implantation. In some embodiments, both the low profile contour ridge 20 of the plate 4 and the reservoir 8 of the plate 4 can contribute to improving the formation of filtration follicles after implantation.

  In some embodiments, the reservoir 8 can hold a collagen-containing material (eg, pericardium, pericardial tissue, and / or donor sclera) on and / or around the plate 4. In some embodiments, the collagen-containing material can be flexible. In some embodiments, the collagen-containing material may be lyophilized. In some embodiments, the collagen-containing material can include a patch.

  In some embodiments, the reservoir 8 can hold a viscoelastic material (eg, sodium hyaluronate and / or cross-linked hyaluronic acid) on and / or around the plate 4. In some embodiments, the viscoelastic material can include an inert viscoelastic material.

  In some embodiments, the reservoir 8 is on and / or around the plate 4 with a collagen-containing material (eg, pericardium, pericardial tissue, and / or donor sclera), viscoelastic material (eg, hyaluronic acid). Sodium and / or cross-linked hyaluronic acid), or combinations thereof.

  Referring to FIGS. 2A-2C, according to one embodiment of the present disclosure, the plate 4 can include a tube receiving end 22, which includes a bottom surface 24 and top surfaces 12, 26. The tube receiving end 22 is integrally formed with the tube holding structure 20, which includes a ridge 20, which is proximal to the top surfaces 12, 26 of the tube receiving end 22 and The ridge 20 has an upper exposed surface 28 and has a width, and is formed in a portion between the bottom surface 24 of the tube receiving end 22 and the upper exposed surface 28 of the ridge 20. A tube receiving hole 30, a mouth 30, or an opening 30 is disposed and / or formed, and the tube receiving hole 30 is integrally formed and / or integrally connected to the tube receiving channel 30 ′. , And the length of the tube receiving channel 30 ′ extends along the entire width of the ridge 20, the plate 4 further comprises a plate channel 10, and the tube receiving channel 30 ′ is connected to the plate channel 10. It is connected.

  In some embodiments, the tube receiving channel 30 ′ can be integrally formed and / or integrally connected with the plate channel 10.

  In some embodiments, the tube receiving channel 30 ′ can have a cylindrical shape, and the tube receiving channel 30 ′ can cover the entire circumference of the tube 6.

  In some embodiments, the outer diameter of the tube 6, the diameter of the recess extending along the entire length of the plate channel 10, the diameter of the tube receiving hole 30 and the diameter of the tube receiving channel 30 'are generally the same or equivalent dimensions. Can be.

  According to embodiments of the present disclosure, the plate 4, tube receiving end 22, tube holding structure 20, ridge 20, tube receiving hole 30, and tube receiving channel 30 'can be integrally formed as one structure. In some embodiments, the plate 4, tube retaining structure 20, ridge 20, tube receiving hole 30, and tube receiving channel 30 'can be integrally formed as one structure by a molding process.

  In some embodiments, the proximal end 14 of the tube 6 can be inserted into the tube receiving hole 30 and then into the tube receiving channel 30 '. The tube receiving channel 30 ′ extends along the entire width of the ridge 20 and can be coupled to the plate channel 10. Using the ridges 20, the tube 6 is connected to the tube receiving hole 30 and the tube during operation and / or movement of the tube 6, during operation and / or movement of the tube 6 during implantation, during the implantation procedure, and / or after implantation. It can be fixed and / or retained in the receiving channel 30 '.

  For example, once the tube 6 has been inserted into the tube receiving hole 30 and then inserted into the tube receiving channel 30 ′ and secured and / or held by the ridge 20 in the tube receiving hole 30 and / or the tube receiving channel 30 ′, Pull, push, move, slide and / or move the tube 6 distally (ie away from the plate 4) to extend the length of the tube 6 (over the receiving hole 30) And / or by pulling, pushing, moving, sliding and / or moving the tube 6 proximally (ie towards the plate 4) (over the receiving hole 30). By reducing the length of 6, the length of the tube 6 can be adjusted or changed. After the tube 6 is inserted into the tube receiving hole 30 and then inserted into the tube receiving channel 30 ′ and fixed and / or held by the ridge 20 in the tube receiving hole 30 and / or the tube receiving channel 30 ′, the tube 6 can be pulled, pushed, moved and / or moved without removing it from the plate 4. This is because the ridge 20 holds the tube 6 firmly or securely in the tube receiving channel 30 '. The tube 6 can be pulled, pushed and / or moved from the tube receiving end 22 of the plate 4 to the reservoir 8 and / or the opposite end of the plate 4.

  Thus, if there is an excess in the length of the tube 6, that portion is covered by the ridge 20 and the tube 6 is placed in a tube receiving channel 30 ′ that extends along the width of the ridge 20. While maintained, it can be cut from the proximal end 14 of the tube 6 that extends proximally away from the ridge 20. Therefore, it is not necessary to remove the tube 6 from the plate 4 for the purpose of changing or adjusting the length of the tube 6 at the proximal end 14 of the tube 6. In addition, the distal end 16 of the tube 6 need not be removed from the anterior chamber (AC) of the eye at any time during the change or adjustment of the length of the tube 6.

  If necessary, the tube 6 can be detached from the tube receiving channel 30 ′ and the plate 4 by pulling and / or pushing the tube 6 distally away from the plate 4.

  Referring to FIGS. 2D-2E, in some embodiments, the tube receiving channel 30 and the tube receiving channel such that the tube receiving channel 30 ′ secures and / or holds the tube 6 within the tube receiving channel 30 ′. 30 'can be formed on the plate 4. In such an embodiment, the tube receiving channel 30 ′ can function as the tube holding structure 20. For example, the tube receiving channel 30 ′ can be formed by cutting away the top surface 12 of the plate 4, the tube receiving channel 30 ′ having a length and a U-shape along the entire length of the tube receiving channel 30 ′. 30 ″ extends and the U-shaped portion 30 ″ of the tube receiving channel 30 ′ allows the tube receiving channel 30 ′ to function as the tube retaining structure 20 without having to remove the tube 6 from the tube receiving channel 30 ′. The tube 6 can be pulled proximally and distally through the tube receiving channel 30 '.

  In some embodiments, the tube receiving channel 30 ′ can cover the entire circumference of the tube 6, and any part of the peripheral surface of the tube 6 that is located within the tube receiving channel 30 ′ is exposed. Never happen. In some embodiments, the tube receiving channel 30 ′ can cover a substantial portion of the circumference of the tube 6, and a portion of the circumference of the portion of the tube 6 that is located within the tube receiving channel 30 ′. Can be exposed. In some embodiments, the tube receiving channel 30 ′ can cover a first portion of the peripheral surface of the tube 6, and the first of the peripheral surfaces of the portion of the tube 6 located within the tube receiving channel 30 ′. Two parts can be exposed.

  In some embodiments, the entire circumference of the tube 6 can be located within the plate channel 10 and a portion of the circumference of the tube 6 can be exposed. In some embodiments, a substantial portion of the circumference of the tube 6 can be located within the plate channel 10 and a portion of the circumference of the tube 6 can be exposed. In some embodiments, a first portion of the circumferential surface of the tube 6 can be located in the plate channel 10 and a second portion of the circumferential surface of the tube 6 can be exposed.

  As shown in FIG. 2F, in some embodiments, the plate 4 can comprise one or more plate channels 10. In some embodiments, the plate 4 can have one or more plate channels 10 formed by cutting away. In some embodiments, the one or more plate channels 10 are removed from the tube retaining structure 20 (eg, a tube receiving channel 30 ′ with a ridge 20 or a U-shaped portion 30 ″ that functions as the tube retaining structure 20) to the reservoir 8. And / or from the reservoir 8 to one or more ends of the plate 4.

  In some embodiments, the one or more plate channels 10 formed by cutting away can be formed by removing material from the plate 4 to form the one or more plate channels 10. The one or more plate channels 10 formed by cutting away allow the GDD 2 to have a low profile as a whole (eg, reduce thickness and / or reduce height). For example, according to some embodiments of the present disclosure, one or more plate channels 10 formed by cutting away may allow the tube 6 to fit within the plate 4 so that the overall profile of the GDD 2 The height can be such that it does not exceed the height of the tube retaining structure 20 (eg, a tube receiving channel 30 ′ with a ridge 20 or a U-shaped portion 30 ″ that functions as the tube retaining structure 20).

  In some embodiments, as shown in FIGS. 2A-2C, the tube retention structure 20 can include a ridge 20. In some embodiments, the ridge 20 can include a ridge 20 with a low profile profile. In some embodiments, the height of the overall outer shape of the GDD 2 is such that the height of the ridge 20 is such that one or more plate channels 10 formed by cutting away allow the tube 6 to fit within the plate 4. The height of the can not be exceeded. In some embodiments, the overall profile height of the GDD 2 is reduced to a low profile profile such that one or more plate channels 10 formed by cutting away allow the tube 6 to fit within the plate 4. The height of the raised portion 20 can be prevented from exceeding.

  In some embodiments, as shown in FIGS. 2D-2E, the tube retaining structure 20 can comprise a tube receiving channel 30 ′, the tube receiving channel 30 ′ having a length; A U-shaped portion 30 ″ extends along the entire length of the tube receiving channel 30 ′, and the U-shaped portion 30 ″ of the tube receiving channel 30 ′ allows the tube receiving channel 30 ′ to act as a tube holding structure 20 and / or. Be able to function. In some embodiments, the overall profile height of the GDD 2 is reduced to a U-shape by allowing one or more plate channels 10 formed by cutting to fit the tube 6 into the plate 4. The height of the tube holding structure 20 with the tube receiving channel 30 ′ containing 30 ″ can be not exceeded.

  3A-3B illustrate a plate 4 according to one embodiment of the present disclosure. FIG. 3B illustrates a cross-section of a tube retention structure 20 according to one embodiment of the present disclosure that includes a ridge 20 that includes a tube receiving hole 30 and a tube receiving channel 30 ′. The tube 6 can be inserted into the tube receiving channel 30 ′ after being inserted into the tube receiving hole 30.

  According to an embodiment of the present disclosure, the plate 4 of the GDD 2 can have a size and / or shape that allows for ease of embedding and / or good effects. In some embodiments, the GDD 2 plate 4 may have a recessed reservoir 8. In some embodiments, the plate 4 of the GDD 2 can have one or more plate channels 10 formed by cutting away. In some embodiments, the plate 4 of the GDD 2 can comprise a tube retention structure 20 that includes a ridge 20 with a low profile profile. In some embodiments, the GDD2 plate 4 may comprise a tube retaining structure 20, which comprises a tube receiving channel 30 ′ that includes a U-shaped portion 30 ″, and the tube receiving channel 30 ′. Functions and / or acts as the tube holding structure 20.

  In some embodiments, the length of plate 4 (front-rear direction) can be about 16 mm or less. In some embodiments, the length of plate 4 (front-rear direction) can be about 16 mm. In some embodiments, the width (left-right direction) of the plate 4 can be about 24 mm or less. In some embodiments, the width (left-right direction) of the plate 4 can be about 24 mm. In some embodiments, the thickness of the plate 4 can be about 1 mm or less. In some embodiments, the thickness of the plate 4 can be about 1 mm.

In some embodiments, the surface area of the plate 4 can be about 250 mm ² to about 350 mm ² . In some embodiments, the surface area of the plate 4 can be from about 250 mm ² to about 360 mm ² . In some embodiments, the surface area of the plate 4 may be about ^{267mm 2, 302mm 2, 313mm 2} , or 315 mm ^2.

  In some embodiments, the plate 4 can be flexible so that the plate 4 can be adapted to the eye of the patient or subject. In some embodiments, the Shore hardness of the plate 4 can be about A60 to A80. In some embodiments, the Shore hardness of the plate 4 can be about A80.

  In some embodiments, the plate 4 can comprise at least one perforation 32. In some embodiments, the plate 4 can comprise two perforations 32. In some embodiments, the plate 4 can comprise up to four perforations 32. In some embodiments, the diameter of each perforation 32 can be about 0.95 mm.

  In some embodiments, the plate 4 can include at least one suture hole 34. In some embodiments, the plate 4 can include two suture holes 34. In some embodiments, the diameter of each suture hole 34 can be about 0.8 mm.

  In some embodiments, the surface of the plate 4 can be smooth and have a low profile profile. In some embodiments, the surface of the plate 4 can include a medical grade elastomer. In some embodiments, the surface of the plate 4 can include medical grade silicone. In some embodiments, the surface of the plate 4 can be polished. In some embodiments, the surface of the plate 4 can comprise polished medical grade silicone.

  In some embodiments, the plate 4 can comprise a recessed portion that forms a reservoir 8 for storing fluid. The reservoir 8 can have any shape. In some embodiments, the reservoir 8 can have an oval shape.

  The plate 4 extends from the tube retaining structure 20 (eg, a tube receiving channel 30 ′ including a ridge 20 or a U-shaped portion 30 ″ functioning as the tube retaining structure 20) to the reservoir 8 and / or from the reservoir 8 to one of the plates 4. One or more plate channels 10 can be provided that can extend to one or more ends.

  The plate channel 10 can hold the tube 6. In some embodiments, the plate 4 is formed by cutting away the plate channel 10 in the plate 4 so that the tube 6 is flush with the plate 4 and the plate 4 is flush with the tube 6. Things can be provided. In other words, the plate channel 10 can be formed by cutting away the plate 4.

  In some embodiments, the plate channel 10 may have a recess or arc that extends along the entire length of the plate channel 10 that allows the tube 6 to be secured within the plate channel 10. In some embodiments, the diameter of the plate channel 10 can be approximately the same size as the outer diameter of the tube 6 used. In some embodiments, the diameter of the plate channel 10 can match the outer diameter of the tube 6, the diameter of the tube receiving hole 30, and / or the diameter of the tube receiving channel 30 '. In some embodiments, the diameter of the recess or arc extending along the entire length of the plate channel 10 is about 0.7 mm or less, about 0.63 or less, about 0.6 mm or less, about 0.45 mm or less, about 0 .43 mm or less, or about 0.35 mm.

  In some embodiments, the plate 4 may comprise a low profile contour ridge 20. The raised portion 20 can be useful for controlling the formation of filtration follicles. The raised portion 20 can hold the tube 6 on the plate 4 and prevent the tube 6 from coming off while the length of the tube 6 is being adjusted. The ridge 20 allows the tube 6 to move freely along the width of the ridge 20, thereby changing or adjusting the length of the proximal end 14 of the tube 6 in front of the ridge 18. Thus, the length 6 of the tube can be changed or adjusted.

  The diameter of the tube receiving hole 30 can coincide with the outer diameter of the tube 6, the diameter of the plate channel 10, and / or the diameter of the tube receiving channel. For example, in some embodiments, the diameter of the tube receiving hole 30 may be 0.7 mm or less, 0.63 mm or less, 0.6 mm or less, 0.45 mm or less, 0.43 mm or less, or 0.35 mm. The outer diameter of the tube 6 can be 0.7 mm or less, 0.63 mm or less, 0.6 mm or less, 0.45 mm or less, 0.43 mm or less, or 0.35 mm.

  FIG. 4A shows a GDD 2 plate 4 according to one embodiment of the present disclosure, wherein the reservoir 8 has a circular shape. FIG. 4B shows a GDD 2 plate 4 according to one embodiment of the present disclosure, wherein the reservoir 8 has a bell shape, ie, a pear shape. FIG. 4C shows a GDD 2 plate 4 according to one embodiment of the present disclosure, wherein the reservoir 8 has an oval shape. Other shaped reservoirs 8 are also conceivable.

  5A-5B show perspective views of various types of tubes 6 according to one embodiment of the present disclosure. The tube 6 can consist of a discharge tube 6. The tube 6 can consist of an anterior chamber tube 6. In some embodiments, the tube 6 can be adjustable and / or changeable.

  In some embodiments, the tube 6 can include a chamfered edge 36 at the distal end 16 of the tube 6. The chamfered edge 36 of the distal end 16 of the tube 6 can facilitate insertion of the tube 6 into the eye. In some embodiments, the distal end 16 of the tube 6 can be chamfered at about 30 °. In some embodiments, the chamfered edge 36 can be cut in advance. By cutting in advance, the chamfered edge 36 has a non-traumatic profile that can prevent eye damage when the tube 6 is inserted and / or when the tube 6 is held in the eye. Can bring.

  In some embodiments, the length of the tube 6 can be about 10 mm to about 20 mm. In some embodiments, the length of the tube 6 can be about 17 mm. In some embodiments, the tube 6 can have a fixed length of about 17 mm.

  In some embodiments, the outer diameter of the tube 6 can be about 0.7 mm or less. In some embodiments, the inner diameter of the tube 6 can be about 0.3 mm or less. In some embodiments, the outer diameter of the tube 6 can be about 0.45 mm or less. In some embodiments, the inner diameter of the tube 6 can be about 0.1 mm or less. In some embodiments, the outer diameter of the tube 6 can be about 0.43 mm or less. In some embodiments, the inner diameter of the tube 6 can be about 0.1 mm or less. In some embodiments, the outer diameter of the tube 6 can be about 0.35 mm. In some embodiments, the inner diameter of the tube 6 can be about 0.050 mm. In some embodiments, the outer diameter of the tube 6 can be about 0.63 mm. In some embodiments, the inner diameter of the tube 6 can be about 0.3 mm. In some embodiments, the outer diameter of the tube 6 can be about 0.6 mm. In some embodiments, the inner diameter of the tube 6 can be about 0.3 mm. In some embodiments, the inner diameter of the tube 6 can be from about 0.1 mm to about 0.3 mm.

  In some embodiments, the wall thickness of the tube 6 can be about 0.2 mm. In some embodiments, the wall thickness of the tube 6 can be about 0.165 mm. In some embodiments, the wall thickness of the tube 6 can be about 0.175 mm. In some embodiments, the wall thickness of the tube 6 can be about 0.15 mm.

  In many embodiments, the outer diameter, wall thickness, and inner diameter of the tube are selected such that both the stiffness of the tube 6 and the resistance to fluid flow are higher than conventional commercially available tubes. Increased tube stiffness helps or significantly assists in the insertion and manipulation of the tube 6 compared to conventional commercially available tubes, thereby simplifying the overall implantation procedure and reducing the time required. .

  In some embodiments, the tube 6 can include a biodegradable cuff 18 that is placed along a longitudinal portion of the tube 6 or a biocompatible and erodible cuff 18, and the cuff 18 covers the outer peripheral surface defined by the said part of the tube 6. FIG. The cuff 18 can act as a flow restriction unit.

  In some embodiments, the cuff 18 can be comprised of a biodegradable material including PLGA, PDLGA, biodegradable polymer, biocompatible polymer, or a combination of one or more thereof. In some embodiments, the cuff 18 can consist of PDLGA.

  In some embodiments, the cuff 18 may have a length that matches the curvature of the eye. In some embodiments, the cuff 18 can have a length that matches the curvature of the eye of the patient or subject. In some embodiments, the length of the cuff 18 can be about 2 mm or less. In some embodiments, the length of the cuff 18 can be about 2 mm. In some embodiments, the length of the cuff 18 can be about 1 mm.

  In some embodiments, the diameter of the cuff 18 can be such that the tube 6 is reduced to about 10 micrometers in diameter. In some embodiments, the outer diameter of the cuff 18 can be about 1.0 mm. In some embodiments, the inner diameter of the cuff 18 can be about 0.5 mm. In some embodiments, the outer diameter of the cuff 18 can be about 0.9 mm. In some embodiments, the inner diameter of the cuff 18 can be about 0.35 mm. In some embodiments, the outer diameter of the cuff 18 can be 0.85 mm. In some embodiments, the inner diameter of the cuff 18 can be about 0.35 mm. In some embodiments, the outer diameter of the cuff 18 can be about 0.86 mm. In some embodiments, the inner diameter of the cuff 18 can be about 0.36 mm.

  In some embodiments, from about 4 weeks to about 8 weeks after implantation, the cuff 18 begins to degrade (and thereby loses its mechanical strength and / or mechanical properties), but GDD2 The wall thickness of the cuff 18 can be about 0.5 mm or less so as to provide a degradation rate that begins less than 4 weeks after implantation and greater than 8 weeks after implantation.

  In some embodiments, the cuff 18 is completely degraded (and thereby its mechanical strength and / or mechanical properties) at about 8 weeks after implantation of GDD2 or about 8 weeks after implantation of GDD2. The wall thickness of the cuff 18 can be about 0.5 mm or less so as to provide a degradation rate).

  Depending on the contents of the cuff 18 and / or the material used to make the cuff 18, the degradation rate of the cuff 18 can be determined. In some embodiments, the cuff 18 can have a wall thickness of about 0.5 mm.

  In some embodiments, the cuff 18 begins to degrade (and thereby loses its mechanical strength and / or mechanical properties) from about 4 weeks after implantation to about 8 weeks after implantation, although GDD2 Of biodegradable materials that do not begin to degrade for less than 4 weeks after implantation and for more than 8 weeks after implantation. In some embodiments, the cuff 18 fully degrades at about 8 weeks after implantation of GDD2, or about 8 weeks after implantation (and thereby completely reduces its mechanical strength and / or mechanical properties). The biodegradable material (which is lost to the fluid), thereby allowing maximum fluid flow.

  In some embodiments, the cuff 18 can be positioned about 6 mm to about 10 mm from the distal end 16 of the tube 6 so as to cover the tube 6. In some embodiments, the cuff 18 can be positioned about 8 mm from the distal end 16 of the tube 6 so as to cover the tube 6. In some embodiments, the tube 6 can include a chamfered edge 36 at the distal end 16 of the tube 6, ie, a chamfered tip 36.

  In some embodiments, the tube 6 can include one or more micropores 38.

  6 (A)-(C) show various types of views of the tube 6 according to one embodiment of the present disclosure, the tube 6 comprising a plurality of micropores 38. FIG. In some embodiments, the tube 6 can include one or more micropores 38.

  FIG. 6A shows a view of the tube 6 viewed from the left side (for example, the 9 o'clock position). FIG. 6B shows a view of the tube 6 as viewed from above (for example, the position at 12 o'clock). FIG. 6C shows a view of the tube 6 viewed from the right side (for example, the 3 o'clock position).

  In some embodiments, the diameter of the one or more micropores 38 can be the same as or substantially the same as the inner diameter of the tube 6. In some embodiments, the two or more micropores 38 can be at about the 12 o'clock position, the 3 o'clock position, and / or the 9 o'clock position along the same longitudinal axis of the tube 6. . In some embodiments, the two or more micropores 38 are staggered along the length of the tube 6 at approximately the 12 o'clock position, the 3 o'clock position, and / or the 9 o'clock position. Can do.

  In some embodiments, the diameter of the one or more micropores 38 can be about 0.3 mm. In some embodiments, the tube 6 is at a micropore 38 at the 12 o'clock position of the tube 6, a microhole 38 at the 3 o'clock position of the tube 6, and / or at 9 o'clock along the tube 6. Certain micropores 38 can be provided. In some embodiments, if there are more than one micropore 38, these micropores 38 can be located along the same longitudinal axis of the tube 6. In some embodiments, if there are two or more micropores 38, these micropores 38 can be staggered along the length of the tube 6.

  In some embodiments, the diameter of the one or more micropores 38 can be about 0.1 mm. In some embodiments, the tube 6 is at a micropore 38 at the 12 o'clock position of the tube 6, a microhole 38 at the 3 o'clock position of the tube 6, and / or at 9 o'clock along the tube 6. Certain micropores 38 can be provided. In some embodiments, if there are more than one micropore 38, these micropores 38 can be located along the same longitudinal axis of the tube 6. In some embodiments, if there are two or more micropores 38, these micropores 38 can be staggered along the length of the tube 6.

  In some embodiments, the tube 6 has a microhole 38 at the 12 o'clock position of the tube 6, a microhole 38 at the 3 o'clock position of the tube 6, and a microhole at 9 o'clock along the tube 6. A hole 38 may be provided. In some embodiments, the micropores 38 can be located along the same longitudinal axis of the tube 6. In some embodiments, the micropores 38 can be staggered along the length of the tube 6.

  In some embodiments, the 6 o'clock position of the tube 6 is typically just above the iris of the eye, so the 6 o'clock position is free of micropores 38. This prevents the iris from being pressed into the micropore and / or sucked into the micropore, resulting in any damage.

  The design of the plate 4 and / or tube 6 of the present disclosure can reduce the failure rate associated with currently available glaucoma drainage devices (GDD) and / or post-operatively associated with currently available GDDs. Complications can be reduced. Furthermore, the design of the plate 4 and / or the tube 6 can facilitate implantation and / or placement.

  The present disclosure also relates to a stability system, ie, a fluid flow control system. According to one embodiment of the present disclosure, the stabilization system comprises a plate 4 of GDD2 (which comprises a plate 4 and a tube 6), and a collagen-containing material applied on and / or around the plate 4. (E.g. pericardium, pericardial tissue and / or donor sclera) and / or viscoelastic material (e.g. sodium hyaluronate and / or cross-linked hyaluronic acid) applied on and / or around plate 4 Can be provided. By combining the plate 4 with a collagen-containing material applied on and / or around the plate 4 and / or a viscoelastic material applied on and / or around the plate 4 A fluid flow control mechanism can be provided that can prevent hypotony that can develop immediately and / or prevent IOP elevation that can occur over time. In some embodiments, the plate 4 can comprise a reservoir 8.

  The GDD 2 plate 4 and the collagen-containing material applied on and / or around the plate and / or the viscoelastic material applied on and / or around the plate cooperate to flow out of the eye. The fluid can be controlled, thereby providing better fluid control over the long term. Applying a collagen-containing material on and / or around the GDD2 plate 4 and / or applying a viscoelastic material onto and / or around the GDD2 plate 4 increases the fluid flow control capability of the GDD2. Can do.

  In some embodiments, the stabilization system may comprise a plate 4 of GDD 2 and a collagen-containing material applied on and / or around plate 4. In some embodiments, the stabilization system may comprise a plate 4 of GDD 2 and a viscoelastic material applied on and / or around plate 4. In some embodiments, the stabilization system includes GDD 2 plate 4 and collagen-containing material applied on and / or around plate 4 or viscoelasticity applied on and / or around plate 4. A substance. In some embodiments, the stabilization system comprises GDD 2 plate 4, collagen-containing material applied on and / or around plate 4, and viscoelasticity applied on and / or around plate 4. A substance. In some embodiments, the collagen-containing material can be flexible. In some embodiments, the collagen-containing material may be lyophilized. In some embodiments, the collagen-containing material can include a patch. In some embodiments, the viscoelastic material can include an inert viscoelastic material.

  According to one embodiment of the present disclosure, the stabilization system includes a plate 4 with a reservoir 8 and a collagen-containing material (e.g., pericardium, heart) applied over and / or around the reservoir 8. Membrane tissue and / or donor sclera) and / or viscoelastic material (eg, sodium hyaluronate and / or cross-linked hyaluronic acid) applied over reservoir 8 and / or around plate 4 Can be provided. By combining the plate 4 with a collagen-containing material and / or a viscoelastic material, it is possible to prevent hypotony that may develop immediately after surgical implantation and / or prevent IOP elevation that may occur over time. A fluid flow control mechanism is obtained.

  FIGS. 7A-7B and Table 1 show variations of currently available glaucoma drainage device implants (bovine pericardial tissue / pericardial patch (eg, Tutopatch) placed on the plate and plate-Tutopatch complex). Comparing the use of cross-linked hyaluronic acid (such as Healaflow) injected on top and both sides of the plate with the use of an unmodified glaucoma drainage device implant as a control The results of an established clinical study, ie a series of clinical cases, are shown.

  Those skilled in the art will appreciate that similar to, substantially similar, equivalent, substantially equivalent, or similar materials can be used for this clinical study, as with Tutopatch, with similar or substantially similar results. . In addition, those skilled in the art can use substantially the same, equivalent, substantially equivalent, or similar substances in this clinical study as in Healaflow, and obtain similar or substantially similar results. I understand. In addition, the currently available glaucoma drainage device used in this clinical study was the drainage device called Ahmed. However, those skilled in the art will appreciate that other currently available drainage devices can be used.

  A clinical study or series of clinical cases was conducted with 30 human patients. Before surgical implantation, 1 day after surgical implantation, 1 week after surgical implantation, 1 month after surgical implantation, 3 months after surgical implantation, and 6 months after surgical implantation. Patients were examined for elevated IOP and hypotension. The patient's IOP was monitored to see if hypotony and / or late IOP elevation occurred. The primary endpoints were (1) success or failure based on mean intraocular pressure (IOP), (2) occurrence of high intraocular pressure phase (defined as IOP> 21 mmHg), (3) onset of hypotonia (IOP <6 mmHg) And (4) the required number of administrations of anti-glaucoma drugs after surgery (for example, anti-glaucoma eye drops).

  In patients treated with a variation of the currently available glaucoma drainage device comprising bovine pericardial tissue / pericardial patch (eg Tutopatch) and cross-linked hyaluronic acid (eg Healaflow), 6 months postoperative IOP (15. 6 ± 4.2 mmHg) and the number of antiglaucoma drugs used (0.4 ± 1.0) are preoperative values (IOP = 22.5 ± 12.3 mmHg, p = 0.026, antiglaucoma) The number of administrations of the drug = 3.2 ± 1.2, p <0.001) was significantly lower. The success rate at 6 months after surgery of a currently available variant of glaucoma drainage device with Tutopatch and Healaflow was 95.2%. Between 1 and 3 months after surgery, 16% of the eyes undergoing surgery had a high intraocular pressure phase with an IOP range of 22-26 mmHg.

  In the control group treated with an unmodified version of the currently available glaucoma drainage device without Tutopatch and Healaflow, ie the patient's control eye, the mean IOP is 17.4 ± 5.1 mmHg at 6 months postoperatively. there were. The number of administrations of the anti-glaucoma drug used decreased from 2.10 + 1.5 to 0.9 ± 0.9 (p = 0.01, student t test) 6 months after the operation. The success rate after surgery of the unmodified version of the currently available glaucoma drainage device without Tutopatch and Healaflow, ie 6 months after implantation, was 70%. The 50% IOP range for the control eyes was 25-43 mmHg during the high intraocular pressure phase seen 1-3 months after surgery.

  FIG. 7A shows the eyes of all patients / subjects in the experimental group (group treated with a variant of the currently available glaucoma drainage device implant with Tutopatch and Healaflow) and the control group (Tutopatch and Healaflow). Figure 6 shows the change in IOP during the pre-operative and 6-month follow-up of the eyes of all patients / subjects in the group treated with unmodified glaucoma drainage device implants not currently available. The broken line with Δ represents the transition of IOP of the experimental group using Tutopatch and Healaflow. The solid line marked with ◆ represents the transition of IOP in the control group that did not use Tutopatch and Healaflow.

  FIG. 7A shows 1 month post-surgical implantation, 3 months post-surgical implantation, and surgical implantation of the experimental group (with a variant of the currently available glaucoma drainage device implant with Tutopatch and Heaflow) Compared to the control group (with currently available glaucoma drainage device unmodified version without Tutopatch and Healaflow), the mean IOP in the next 6 months shows a little straight line of variation indicating a stable and low IOP level. It is clearly shown that you are following.

  FIG. 7B shows the anti-glaucoma required in the experimental group (with a currently available variant of glaucoma drainage device implant with Tutopatch and Healaflow) in the follow-up before and 6 months after surgery. The number of doses of the drug and the number of doses of anti-glaucoma drug required in the control group (having an unmodified version of the glaucoma drainage device implant currently available without Tutopatch and Healaflow) are shown. The broken line with Δ represents the number of administrations of the anti-glaucoma drug required in the experimental group using Tutopatch and Healaflow. The solid line with ◆ represents the number of administrations of the anti-glaucoma drug required in the control group that did not use Tutopatch and Healaflow.

  As shown in FIGS. 7A-7B and Table 1 below, the use of collagen-containing materials (eg, bovine pericardial tissue / pericardial patch) and the use of viscoelastic substances (eg, cross-linked hyaluronic acid) The results of surgical drainage device implant surgery improved. The use of collagen-containing materials and the use of viscoelastic substances significantly reduced IOP, significantly reduced the number of administrations of anti-glaucoma drugs, and significantly reduced the incidence of the intraocular pressure phase.

  According to clinical studies or series of clinical cases, collagen-containing materials (eg pericardium, pericardial tissue, donor sclera and / or pericardial patches) and viscoelastic substances (eg sodium hyaluronate and / or cross-linked hyaluronic acid) Has been shown to improve the stability of IOP after surgical implantation by using it with a glaucoma drainage device, thereby reducing the incidence of ocular IOP and hypotension.

Method for Producing Glaucoma Discharge Device of the Present Disclosure The present disclosure also relates to a method for producing the glaucoma discharge device (GDD) 2 described above.

  According to one embodiment of the present disclosure, the plate 4 is provided with a medical grade elastomeric material (eg, medical grade silicone) and the medical grade elastomeric material is molded to form the plate 4. Can be manufactured. Subsequently, the molded plate 4 of medical grade elastomeric material can be polished to provide a smooth surface. The plate 4 comprises a tube holding structure 20, a tube receiving hole 30, a tube receiving channel 30 ′, a reservoir 8, one or more plate channels 10, one or more perforations 32, and / or one or more suture holes 34. Can be formed.

  According to one embodiment of the present disclosure, the tube 6 is prepared by providing a medical grade elastomeric material (eg, medical grade silicone) and extruding the medical grade elastomeric material to form the tube 6. Can be manufactured. Laser cutting can be used to create a chamfered edge 36 at the distal end 16 / inlet end 16 / inlet end 16 of the tube 6. One or more micropores can be formed along the length or side of the tube 6 using laser drilling.

  In some embodiments, the method of manufacturing the tube 6 includes providing a medical grade elastomeric material, extruding the medical grade elastomeric material to form the tube 6, Laser cutting the distal end 16, i.e., the inlet end 16, and laser cutting the distal end 16, i.e., the inlet end 16, of the tube 6, and / or lasering. Forming one or more micro holes 38 along the longitudinal direction or side of the tube 6 by a perforation method.

  In some embodiments, the method of manufacturing the tube 6 includes providing a medical grade elastomeric material and molding the medical grade elastomeric material to form the distal end 16, ie, the inlet end 16. Forming a tube 6 having a chamfered edge 36 and / or having one or more micropores 38 along the length or side of the tube 6.

  In some embodiments, the method of manufacturing the tube 6 includes providing a medical grade elastomeric material and molding the medical grade elastomeric material to form the tube 6 having a chamfered edge 36. And forming one or more micro holes 38 along the longitudinal direction or side of the tube 6 by laser drilling.

  According to one embodiment of the present disclosure, the biodegradable cuff 18 provides a material comprising PDLGA, PLGA, biodegradable polymer, biocompatible polymer, or a combination of one or more thereof, and the material Can be produced by forming the cuff 18 or the cuff tube 18.

  According to one embodiment of the present disclosure, the glaucoma drainage device (GDD) 2 can be manufactured by preparing or manufacturing the plate 4 and the tube 6 and assembling the plate 4 to the tube 6. In some embodiments, the plate 4 and the tube 6 can be assembled by manually passing the tube 6 through the tube receiving hole 30 and the tube receiving channel 30 ′ of the plate 4. In some embodiments, the plate 4 and the tube 6 can be assembled by passing the tube 6 through the tube receiving hole 30 and the tube receiving channel 30 'of the plate 4 using an automated instrument / automatic device. In some embodiments, the plate 4 can be overmolded to the tube 6.

  According to one embodiment of the present disclosure, the cuff 18 and the tube 6 can be manufactured as separate parts. In some embodiments, the cuff 18 and tube 6 can be pre-cut to a desired length. In some embodiments, the tube 6 can be manually threaded through the cuff 18. In some embodiments, the tube 6 can be passed through the cuff 18 using an automatic instrument / automatic device.

Method of Implanting the Glaucoma Discharge Device of the Present Disclosure The present disclosure also relates to a method of implanting the glaucoma discharge device (GDD) 2 described above in a patient or subject.

  According to one embodiment of the present disclosure, the clinician can incise the subtenon / subconjunctival space by the size of the plate 4 of GDD2. A collagen-containing material can be placed on and / or around the plate 4 to form a plate-collagen complex, which can then be inserted. In some embodiments, the collagen-containing material can consist of pericardium, pericardial tissue, and / or donor sclera. In some embodiments, the collagen-containing material can be flexible. In some embodiments, the collagen-containing material can include a patch.

  The plate 4 can be arranged to cover the sclera of the eye. The plate 4 can have a shape and / or dimensions that facilitate the embedding of the plate 4 and the GDD 2.

  The tube 6 of the GDD 2 can include a proximal end 14 / outflow end 14 that is removably coupled to the plate 4. The tube 6 may also include a distal end 16 / inlet end 16 / inlet end 16 that extends away from the plate 4, with the distal end 16 / inlet end 16 / inlet end 16 being The length is long enough to extend into the anterior chamber of the eye. The distal end 16 / inlet end 16 / inlet end 16 is the end inserted into the eye. The surgeon or clinician can insert the tube 6 through an incision in the eye. The tube 6 may comprise a chamfered edge 36 at the distal end 16 / inlet end 16 / inflow end 16 of the tube 6 that is useful for insertion of the tube 6.

  After the tube 6 is inserted into the eye, the tube 6 is removed from either end of the tube retaining structure 20 (eg, proximal end 14 / outflow end 14 of the tube 6 proximal to the tube retaining structure 20). And / or just above the tube retention structure 20 and through the above portion of the tube 6 (not located in the anterior chamber of the eye) and adjusted to a length suitable for the patient's eye be able to. The tube 6 is cut from the proximal end 14 / outflow end 14 closer to the plate 4 so that the surgeon or clinician removes the tube 6 from the eye and pulls the tube 6 to the appropriate length. No need to cut. As a result, the smooth outer shape of the tube 6 can be maintained at the distal end 16 / inlet end 16 / inlet end 16 entering the eye.

  The cuff 18 acting as a flow restrictor in the tube 6 and GDD 2 can eliminate the extra step of using a suture knot to create a primary flow restrictor. When using currently available valveless glaucoma drainage devices, the extra step of creating a primary flow restriction using a suture knot is common.

  The plate 4 can be secured to the sclera by one or more suture holes 34 about 8.5 mm behind its edge.

  Prior to closing the subconjunctival space / subtenon, an inert viscoelastic material (eg, cross-linked hyaluronic acid) can be injected over and / or around the plate-collagen complex. Combining GDD2 plate 4 with a collagen-containing material on and / or around plate 4 and / or viscoelastic material on and / or around plate 4 can act as a stable system. A stable system comprising plate 4 and collagen-containing material on and / or around plate 4 and / or an inert viscoelastic material on and / or around plate 4 can serve for fluid flow control.

  FIGS. 8A-8H and Table 2 show desktop data results of a natural flow simulation comparing the use of a representative glaucoma drainage device (GDD) 2 according to the present disclosure with the use of a commercially available device Baerveldt variant. Show. In a variation of the instrument Baerveldt, the tube incorporates or forms a 200 micrometer seam to reduce the diameter of the tube, thereby improving the fluid flow in the tube / the resistance of fluid flow through the tube. I let you. This variation may also be applied in clinical settings. A situation where the initial intraocular pressure is ≧ 21 mmHg is simulated by natural flow. Due to the pressure difference, fluid is drained from the eye.

  FIG. 8A shows the transition of the first set of intraocular pressure reduction simulation over time when fluid is drained through a variant of the device Baerveldt, and FIG. 8C shows the first intraocular pressure reduction simulation over time. The transition of the pair of 2 is shown. The broken line with ◆ represents the transition of intraocular pressure simulation, and the solid line represents an exponential curve fitted to the simulation data.

FIG. 8B shows the transition of the first set of intraocular pressure simulations with respect to the flow rate, and FIG. 8D shows the transition of the second set of intraocular pressure simulations with respect to the flow rate. The intraocular pressure and the deformation of the instrument Baerveldt It shows a mathematical relationship with the flow rate of fluid through the article (e.g., based on the Poiseille equation or equivalent to a relationship that can be derived using the Poiseille equation). The broken line with ◆ represents the transition of intraocular pressure simulation with respect to the flow rate. A solid line represents a straight line fitted to the simulation data. The slope of the fitted straight line determines the resistance of the instrument to the flow rate of fluid in the tube / flow rate of fluid through the tube. That is, the resistance of the variant of the instrument Baerveldt is approximately 5 × 10 ¹⁰ (mmHg / (m ³ / sec)) when read from both FIGS. 8B and 8D.

  FIG. 8E shows the transition of the first set of intraocular pressure reduction simulation over time when the glaucoma drainage device (GDD) 2 according to the present disclosure is used, and FIG. 8G shows the intraocular pressure reduction over time. The transition of the second set of simulations is shown. The broken line with ◆ represents the transition of intraocular pressure reduction simulation, and the solid line represents an exponential curve fitted to the simulation data.

FIG. 8F shows the transition of the first set of intraocular pressure simulations with respect to the flow rate, and FIG. 8H shows the transition of the second set of intraocular pressure simulations with respect to the flow rate, and the intraocular pressure and glaucoma according to the present disclosure. 2 shows a mathematical relationship with the flow rate of fluid through the evacuation device (GDD) 2 (for example, based on the Poiseille equation or equivalent to a relationship that can be derived using the Poiseille equation). The broken line with ◆ represents the transition of intraocular pressure simulation. A solid line represents a straight line fitted to the simulation data. The slope of the fitted straight line determines the resistance of the instrument to the flow rate of fluid in the tube / flow rate of fluid through the tube. That is, the resistance of this glaucoma drainage device (GDD) 2 according to the present disclosure is about 2 × 10 ¹¹ (mmHg / (m ³ / sec)) when read from both FIGS. 8F and 8H.

  Table 2 below summarizes the average resistance of the instrument Baerveldt variant and the average resistance of the glaucoma drainage device (GDD) 2 according to the present disclosure (calculated from natural flow simulation). In Table 2, “System R” is obtained using a variation of the instrument Baerveldt or an experimental device (eg, tube, T-connector, etc.) in which the glaucoma drainage device (GDD) 2 according to the present disclosure is not fluidly coupled. Refers to the results of experimental measurements. The results in Table 2 show that the glaucoma drainage device (GDD) 2 according to the present disclosure exhibits or generates a higher resistance than the variant of the device Baerveldt. Increased resistance reduces the rate at which fluid flows out of the eye chamber. Thereby, when the intraocular pressure of the eye is high in the initial stage, it is possible to prevent hypotony immediately after the operation.

  FIGS. 9A-9D and Tables 3A-3C show the use of the glaucoma drainage device (GDD) 2 according to the present disclosure and a Baerveldt variant of a commercially available device (in the same or essentially the same manner as described above). The table data results of a constant flow simulation comparing the use of the tube with 200 micrometer seams) are shown. For the results shown in FIGS. 9A-9D and Tables 3A-3C, the pressure was zeroed before the start of the experiment. Simulate the situation where the eye reaches a stable intraocular pressure of about 15-20 mmHg after initial discharge from high pressure with a constant flow rate. The eye continues to produce approximately 2 μl / min of fluid, which is simulated by a fluid pump, and the fluid is constantly evacuated through the instrument to maintain an intraocular pressure of 15-20 mmHg.

  FIG. 9A and Table 3A show three sets of changes in intraocular pressure simulation with respect to the flow rate using a modified version of the instrument Baerveldt (with a 200-micrometer seam in the tube). In FIG. 9A, the broken line with ◆ represents the transition of the first set of intraocular pressure simulations with respect to the flow rate, and the broken line with ■ represents the transition of the second set of intraocular pressure simulations with respect to the flow rate. The attached broken line represents the transition of the third set of intraocular pressure simulation with respect to the flow rate. The broken line with ◆ in FIG. 9B represents the average of the results of three sets of intraocular pressure simulations with respect to the flow rate in FIG. 9A. The solid line in FIG. 9B represents a straight line fitted to the average of the simulation data. The resistance of the instrument is obtained by the inclination of the fitted straight line. That is, the resistance force of the deformed product of the instrument Baerveldt is about 0.263 (mmHg / (μl / min)) when read from FIG. 9B.

  FIG. 9C and Table 3B show the transition of two sets of intraocular pressure simulations versus flow rates using the glaucoma drainage device (GDD) 2 according to the present disclosure. In FIG. 9C, the broken line with ◆ represents the transition of the first set of intraocular pressure simulation with respect to the flow rate, and the broken line with ■ represents the transition of the second set of intraocular pressure simulation with respect to the flow rate. Yes. The broken line with ● in FIG. 9D represents the average of the results of two sets of intraocular pressure simulations for the flow rate in FIG. 9C. The dotted line in FIG. 9D represents a straight line fitted to the average of the simulation data. The resistance of the instrument is obtained by the inclination of the fitted straight line. That is, the resistance force of the glaucoma drainage device (GDD) 2 according to the present disclosure is about 1.8051 (mmHg / (μl / min)) when read from FIG. 9D.

  Table 3C below summarizes the average resistance of the variant of the instrument Baerveldt and the average resistance of the glaucoma drainage instrument (GDD) 2 according to the present disclosure (calculated from a constant flow simulation). In Table 3C, “System R” was obtained using a variation of Baerveldt or an experimental device (eg, tube, T-connector, etc.) in which the glaucoma drainage device (GDD) 2 according to the present disclosure is not fluidly coupled. Refers to experimental measurement results. The results in Table 3C indicate that the glaucoma drainage device (GDD) 2 according to the present disclosure generates a higher resistance than the variant of the device Baerveldt. Thereby, after reaching a stable intraocular pressure, it is possible to prevent postoperative hypotony that may develop.

  To evaluate the in vivo safety and technical performance of the glaucoma drainage device (GDD) 2 according to the present disclosure for treating glaucoma, a preclinical study in a rabbit model was also conducted. The glaucoma drainage device (GDD) 2 according to the present disclosure was evaluated for safety assessment items of biocompatibility, potential eye irritation, postoperative complications, and ease of implantation.

  Devices according to the present disclosure include post-operative complications (including inflammation, infection, device occlusion, device exposure / extrusion, cornea or lens damage, eye grease, strabismus discomfort, eye discomfort, etc.) Should have at least an equivalent safety profile compared to commercially available devices.

  It has been found that GDD2 according to the present disclosure is easier to implant than instruments currently on the market. In rabbits, no inflammation or infection was observed, indicating the biocompatibility of the glaucoma drainage device (GDD) 2 according to the present disclosure. At the time of excision, GDD2 was found to be visible and no rejection was observed.

  Table 4 below shows the intraocular pressure (IOP) (mmHg) of the rabbits of the control group and the experimental group. The control group is rabbits that have not been implanted / used with GDD2, and the experimental group is rabbits that have been implanted with GDD2. In Table 4, the control group includes sample numbers 0637 (control) and 0638 (control), and the experimental group includes sample numbers 0637, 0638, and 0639 (L is the left eye, R is Shows the right eye). Table 4 shows the results of IOP before the treatment of the experimental group, and at the first, second, sixth, and twelfth weeks after the treatment of the experimental group.

  As shown in Table 4, no persistent hypotony was observed in the experimental group after 2 weeks. Sample number 0639R showed low intraocular pressure (IOP), but the image did not show a shallow anterior chamber. The results in Table 4 also show that the intraocular pressure of all eyes is close to a normal value. This shows that the fluid is flowing into GDD2 over the considered period.

Method for Controlling Intraocular Pressure The present disclosure further relates to a method for controlling intraocular pressure (IOP) of a patient or subject by using the glaucoma drainage device (GDD) 2 described above.

  According to embodiments of the present disclosure, IOP can be controlled by providing GDD2 and implanting GDD2 in a patient or subject. The GDD 2 includes a plate 4 and a tube 6.

  In some embodiments, the tube 6 can comprise a cuff 18, which comprises a biodegradable cuff 18 or a biocompatible erodible cuff 18.

  In some embodiments, the cuff 18 can contract the tube 6 to a diameter that results in a fluid flow rate through the tube 6 of about 2 μL / min, thereby preventing early hypotony.

  As the fibrous tissue overlying the plate 4 is formed (eg, filter follicles are formed), the cuff 18 reduces the force with which the cuff 18 compresses the tube 6, thereby preventing late IOP increases. Can be gradually decomposed.

  In some embodiments, the cuff 18 begins to degrade after four weeks of implantation (and thereby begins to lose its mechanical strength and / or mechanical properties), thereby draining excess fluid. (Which may lead to hypotony in the early stages (eg, before fibrous tissue is formed on the plate 4 of GDD2)) and begins to degrade 8 weeks before implantation, thereby reducing efflux Increase to minimize excess fluid retention, which may cause postoperative IOP elevation.

  In some embodiments, the cuff 18 can completely degrade and lose its mechanical strength and / or mechanical properties about 8 weeks after implantation or about 8 weeks after implantation. .

  In some embodiments, the plate 4 can comprise a reservoir 8, which is a patch material (eg, pericardium, pericardial tissue, and / or on top of and / or around the plate 4). (Or donor sclera) and / or an inert viscoelastic material (eg, sodium hyaluronate and / or cross-linked hyaluronic acid) on and / or around the plate 4. The plate 4 of GDD2 having a collagen-containing material on and / or around the plate 4 and / or having a viscoelastic material on and / or around the plate 4 can function as a stable system.

  In some embodiments, the stabilization system includes GDD 2 plate 4, collagen-containing material applied on and / or around plate 4, and viscosity applied on and / or around plate 4. And an elastic material. In some embodiments, the collagen-containing material can be flexible. In some embodiments, the collagen-containing material may be lyophilized. In some embodiments, the collagen-containing material can include a patch. In some embodiments, the viscoelastic material can comprise an inert viscoelastic material.

  Reservoir 8 allows the initial fluid flow to immediately reduce intraocular pressure. The collagen-containing material can apply additional pressure to the plate 4 to slow down the fluid flow to the conjunctiva and prevent over-drainage that can lead to hypotonia. Collagen-containing materials can also tighten the conjunctiva, thereby preventing artificial thickening and elongation and helping to form filter follicles, thereby preventing late IOP elevation. Viscoelastic materials can lift and expand the conjunctiva and prevent scarring. The viscoelastic substance can also help to form filter follicles and help prevent late IOP elevation.

  The cuff 18 and a stabilizing system (eg, plate 4 and collagen-containing material and / or viscoelastic material) can be used together to control IOP, or can be used independently to control IOP.

Methods for Preventing Complications The present disclosure further relates to methods for preventing complications associated with currently available glaucoma drainage devices (GDD).

  According to one embodiment of the present disclosure, complications associated with currently available GDD can be prevented by providing the glaucoma drainage device (GDD) 2 described above and implanting the GDD2 in a patient or subject. it can.

  GDD2 can have a low profile profile to help form filter follicles and / or prevent conjunctival extension. Conjunctival extension and / or deformation can interfere with conjunctival capillary blood flow, leading to ischemia and thereby conjunctival erosion. GDD2 can have a smooth profile and smooth edges to prevent damage and scarring.

  The smaller the diameter of the tube 6, the smaller the risk of damaging the cornea when the tube 6 is inserted into the eye and / or when the tube 6 is placed in the eye. Thus, smaller dimensions and / or diameters of the tube 6 can help prevent corneal decompensation and / or corneal damage.

  The smaller the size and / or diameter of the tube 6, the lower the contour can be realized on the conjunctiva, and the erosion of the tube 6 can be minimized by the low contour.

  The tube 6 pre-cut and chamfered can provide an atraumatic profile that can prevent eye damage when inserted into the eye and / or placed in the eye.

  The length of the tube 6 of the GDD 2 can be easily adjusted and customized without having to remove the tube 6 from the eye and without having to reinsert the tube 6 into the eye. As a result, the risk of anterior chamber corner and iris trauma can be prevented. This can prevent the risk of anterior chamber corner and iris bleeding. In addition, the adjustable tube 6 of the present disclosure eliminates the risk of hypertrophy of the path through which the tube 6 is inserted, since it is not necessary to remove the tube from the eye, customize the tube length, and reinsert the tube into the eye. This reduces the associated risk of leakage around the tube and / or hypotony.

  One or more micropores 38 in the tube 6 allow the GDD 2 to function continuously. When the distal end of the tube 6 is blocked, the fluid can flow out through one or more micro holes 38 in the tube 6. That is, the one or more fine holes 38 positioned along the longitudinal direction of the tube 6 can prevent blockage.

  A cuff 18 that acts as a flow restrictor for GDD2 and / or a stabilizing system (eg, plate 4 and collagen-containing material and / or viscoelastic material) for controlling fluid flow in GDD2 may cause early ocular hypotension. And / or can help prevent late IOP increases. Early hypotony and late IOP elevation are generally associated with poor fluid flow control.

  Collagen-containing materials (eg, pericardium, pericardial tissue, and / or donor sclera) can tension the conjunctiva and minimize artificial stretching and / or thickening. Thus, the collagen-containing material can minimize and / or prevent scarring. Collagen-containing materials can also minimize the occurrence and / or severity of the IOP elevation phase.

  Viscoelastic materials (eg, sodium hyaluronate and / or cross-linked hyaluronic acid) can lift and expand the conjunctiva to prevent scarring and concomitant malformation of filter bleb.

  In some embodiments, GDD2, plate 4, and / or tube 6 can be used to treat a mammal. In some embodiments, the mammal can be a human. In some embodiments, the human can be an adult. In some embodiments, the human can be a child.

Applications In non-limiting exemplary applications, the glaucoma drainage device of the present disclosure can be used to reduce intraocular pressure (IOP) in glaucoma patients.

  Various aspects and embodiments have been disclosed herein, but those skilled in the art will be able to read the above disclosure and various other modifications of the present invention without departing from the spirit and scope of the present invention. Obviously, and adaptations can be recognized, and all such variations and adaptations are intended to be included within the scope of the appended claims. The various aspects and embodiments disclosed herein are for purposes of illustration and are not intended to be limiting, with the true scope of the invention being indicated by the appended claims.

A tenth aspect of the present disclosure is a method of implanting the above implantable intraocular device, wherein a subtenon / subconjunctival space having a dimension corresponding to a dimension of the plate is formed in the eye, and Place the plate within the subconjunctival space to cover the membrane, secure the plate with sutures, insert the distal end of the tube into the anterior chamber of the eye, and connect the proximal end of the tube Providing a method that can include customizing the length of the tube by cutting.

Claims (20)

An implantable intraocular device comprising a plate,
The plate is
A flexible material;
A tube holding structure integrally formed with the plate;
With
An implantable intraocular device in which the tube holding structure is configured to hold the tube fastened to the plate by the tube holding structure when the tube is moved relative to the tube holding structure.   The implantable intraocular device of claim 1, wherein the tube retaining structure comprises at least one of a low profile contour ridge and a tube receiving channel having a U-shape. The plate is
At least one plate channel;
A reservoir,
The implantable intraocular device according to claim 1, further comprising:   4. The at least one plate channel is formed by cutting away an outer surface of the plate, and the diameter of the at least one plate channel corresponds to the outer diameter of the tube. Implantable intraocular device.   4. The implantable intraocular device of claim 3, further comprising a collagen-containing material and / or a viscoelastic material that covers at least a portion of the upper surface of the plate and / or at least a portion of the reservoir. The embedding according to claim 1, wherein the width (left-right direction) of the plate is about 24 mm or less, the length (front-rear direction) is about 16 mm or less, and / or the surface area is about 250 mm ² to about 360 mm ^2. Intraocular device.   The implantable intraocular device of claim 1, further comprising a tube having a length and having a proximal end and a distal end.   8. The implantable intraocular of claim 7, wherein the tube further comprises one or more micropores with an inner diameter approximately equal to the inner diameter of the tube, and wherein the distal end of the tube is optionally chamfered. Instruments.   8. The implantable intraocular device of claim 7, further comprising an outer diameter of the tube of 0.7 mm or less, a length of about 10 mm to about 20 mm, and / or an inner diameter of about 0.3 mm or less. .   8. The implantable intraocular device of claim 7, wherein the tube further comprises a biodegradable cuff.   11. The implantable intraocular device of claim 10, wherein the length of the biodegradable cuff matches the curvature of the eye.   The diameter of the biodegradable cuff reduces the inner diameter of the tube, and the reduced inner diameter of the tube allows a flow rate of fluid through the tube to be about 2 μl / min or less. Implantable intraocular device.   The biodegradable cuff has a length of about 2 mm or less and / or a wall thickness of about 0.5 mm or less, and the biodegradable cuff is about 6 mm to about 10 mm from the distal end of the tube. 11. The implantable intraocular device according to claim 10, wherein the implantable intraocular device is disposed.   11. The biodegradable cuff starts to degrade from about 4 weeks after implantation to about 8 weeks from implantation, but does not begin to degrade less than 4 weeks after implantation and more than 8 weeks after implantation. Implantable intraocular device. A method for manufacturing or implanting an implantable intraocular device, comprising:
Providing and molding a medical grade elastomeric material to produce the implantable intraocular device plate;
The plate includes a flexible material and a tube holding structure integrally formed with the plate,
A method wherein the tube holding structure is configured to secure the tube to the plate when moving the tube relative to the tube holding structure.   The method further comprises at least one of polishing the molded medical grade elastomeric material, passing the tube through a tube receiving hole in the plate, and overmolding the plate into the tube. Item 16. The method according to Item 15. Forming in the eye a subtenon / subconjunctival space with dimensions corresponding to the dimensions of the plate;
Placing the plate in the subconjunctival space so as to cover the sclera of the eye, and fixing the plate with a suture;
Inserting the distal end of the tube into the anterior chamber of the eye;
16. The method of claim 15, further comprising:   18. The method of claim 17, wherein excess fluid is drained from the anterior chamber via the tube and diffuses through the plate, thereby reducing excess intraocular pressure (IOP).   Without removing the distal end of the tube from the anterior chamber of the eye and with the tube secured in the tube holding structure, away from the tube receiving hole corresponding to the tube holding structure, or The method of claim 17, further comprising adjusting the length of the tube by moving the tube toward the tube receiving hole.   20. The method of claim 19, further comprising cutting excess tube length from the proximal end of the tube extending away from the tube receiving hole while the tube remains fixed in the tube holding structure. .